- Provide leadership across the Quality organization to promote and drive strategic thinking and innovative approaches to change the business
- Drive and lead various change/transformation and continuous improvement initiatives and facilitate development of Quality Strategies to ensure a harmonized and integrated quality approach that will provide oversight and governance to enable Site Quality to successfully change the business
- Build and promote a Quality Culture through collaboration and partnerships, innovation, continuous improvement, and a learning environment that includes knowledge and best-practices sharing
- Leverage science, systems, and people as key elements to direct the Quality Culture that focuses on patients, including regulatory compliance, patient safety, continuous improvement, pro-cess efficiency, and problem prevention
- Responsible for a timely and effective communication and escalation process to Site Quality Head in order to raise quality and safety issues
- Responsible for the department expenses and department budget planning
- Ensures adherence to EHS program
- Lead and facilitate development of strategies for an integrated quality approach & culture in the organization
- Drive and coordinate Quality projects, initiatives, process improvements and best practice sharing across the Site quality organization; including appropriate tools and training
- Provide executive sponsorship to Quality Initiatives to ensure initiatives stay on track and deliver results
- Build and lead strong foundation for collaboration and ensure management of interdependencies across the organization with all internal business partners
- Lead overview on budget and resource management for the Site Quality Leadership
- Lead and manage external influencing activities to track leadership involvement in key external industry & regulatory groups and maintain strong networks with industry groups and contacts in order to stay current with industry best practices and trends
- Develop a framework for innovation & new technology and drive involvement of SCIENCE-based thinking to ensure application of new technology and continuous improvement (e.g. OPEX/Lab Transformation)
- Provide leadership in coordination of talent management processes and people development with Site QLT and HR business partners.
- Provide leadership to support to the Site QLT on team meetings, strategic agenda creation and minutes
- Actively champion and role model our Quality Culture of continuous improvement, learning organization principles and innovation as well as adherence to the principles and values of Takeda-ism.
- Knowledge of the local and international regulatory regulations including GXP, ICH, other related guidelines.
- Knowledge in API, solid dosage forms, parenteral technology, biologics or combination products.
- Strong analytical and problem solving skills to make key decisions regarding potential risks associated with product quality or regulatory violations.
- Excellent verbal and written communication skills in both Japanese and English.
- Adaptive communication and presentation skills to effectively reach different levels, including senior management.
- Skilled in Microsoft Office applications (Excel, Powerpoint, Word)
- Experience/expertise with TrackWise Deviation/CAPA, Change Control Management (CCM), SAP and Electronic Batch Management (EBM) systems preferred.
- Strong leadership skills and demonstrated success in managing a team.
- Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, influence key stakeholders, cooperate as a team leader or team member, share information and deliver results with a team.
- Adopt and exemplify the Takeda leadership behaviors throughout the GQ organization and Osaka Plant.
- Must have the ability to act as a change agent as well as effectively lead and motivate team members to achieve team goals.
- Must be able to deal with ambiguity, and make decisions under stressful conditions.
- Great sense of urgency.
- Interacts with the Site Quality Head and all site functions (EHS, HR, Finance, IT, Manufacturing, Engineering, Supply Chain, etc.)
- Interacts with global Quality functions and Regulatory Affairs, as well as local and global regulators.
- Interacts frequently with subordinates, functional peers, and the Senior Leadership Team.
- Strong knowledge of Quality Risk Management principles.
- Should be current in knowledge of state-of-the art processes and systems related to production as well as control of the products.
- Identify and implement strategic opportunities to drive cost reductions/process improvements in site-business.
- Lead and engage employees by initiatives of "Quality Culture", "AGILE 4.0" "Digital" to drive continuous improvements.
- Key stakeholders include but not limited to: Quality Control, Manufacturing, Supply Chain, Distribution, IT, Manufacturing Sciences, Pharmacovigilance, Regulatory Affairs, and Health Authorities.
- Bachelor's degree in Chemistry, Pharmacy, Engineering, Biology or related discipline.
- At least 10 years of management experience in the following areas in the pharmaceutical industry: Quality assurance, Quality Control; understanding of the requirements for manufacturing, plant utilities, computer systems and project management.
- In depth knowledge of applicable regulations and laws for medicinal products, such as FDA CFR, ICH, GMPs and guidelines.
- Well-knowledge related to Manufacturing, Finance, EHS and HR (incl. Labor law)
- Strong leadership skills (i.e. Communication, Coaching, Project Management, Decision Making, Problem Solving, Team building and etc.)
- Business level of English skill is necessary (both verbal and written)
- License for pharmacist
- Lean-6-sigma certification
- MBA
- Experience of overseas assignment.
- Preferred to have experience in managing team with applicable EHS perspectives such as waste, waste water, exhaust gas, noise, GHG reduction, health, and safety. (5 years for department head and 3 years for Group Managers)
- Preferred to have experience in ISO 14001/45001 management system to carry out continuous improvement of site.
- Some travels will be required.
- This job description is not designed to be a complete list of all duties and responsibilities required of the position.
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説明
Description
Please note this job requiresbusiness level Japanese in speaking, writing, and reading.
"Better Health for People, Brighter Future for the World" is the purpose of a company.We aim to create a diverse and inclusiveorganization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transformthe lives of patients. We're looking for like-minded professionals to join us.
Takeda isa global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, whichhas been passed down since the company's founding. Takeda-ismincorporates and with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.
Change the business in line with standard site Quality Organizational Model:
・
・
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Technical/Functional (Line) Expertise
Leadership
Decision-making and Autonomy
Interaction
Innovation
Complexity
Preferred
Allowances: Commutation, Housing, Overtime Work etc.
Salary Increase: Annually
Bonus Payment: Twice a year
Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45 / (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45
Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.
Flexible Work Styles: Flextime, Telework
Click to find out Takeda's Diversity, Equity & Inclusion
Better Health, Brighter Future
Locations
Osaka (Juso), JapanWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time
